WuXi Biologics, a contract research, development and manufacturing organization (CRDMO) headquartered in Shanghai, China, has completed the first GMP production campaign at its MFG17 drug substance facility at the Shanghai Fengxian site, with the manufacturing process execution completed with zero deviations.

MFG17 is the company’s 25th drug substance manufacturing facility globally and is equipped with multiple single-use bioreactors providing total manufacturing capacity of 9,000 liters, supporting 80 to 100 batches annually. The facility is said to support multiple process modes including fed-batch, perfusion, intensified perfusion, and fully automated continuous manufacturing. Critical process parameters remained stable while yields reached expected levels during the initial production campaign, according to the company.

WuXi Biologics said MFG17 will work closely with other operations at the Fengxian site to support integration from discovery through commercial manufacturing and from drug substance to drug product.

Chris Chen, CEO of WuXi Biologics, contends in a statement that the successful GMP production at MFG17 strengthens the company’s manufacturing capabilities and provides high-quality manufacturing support for customers as they advance biologics to patients.

WuXi Biologics said its global network spans China, the U.S., Ireland, Germany, and Singapore, with 25 drug substance facilities and 18 drug product facilities currently in operation. By the end of 2025, the company had delivered more than 2,350 drug substance batches and more than 2,260 drug product batches and passed 46 regulatory inspections worldwide with a 100% success rate and no critical findings, according to the company.

The announcement follows WuXi Biologics’ receipt last week of its fourth EMA GMP certification for its Biosafety Testing Center in Suzhou, which supported European Union marketing authorization applications for 19 biologics from 13 clients following an inspection with zero critical findings.